Medical Information Why Volunteer? Clinical Trials of Medical Treatments

The Food and Drug Administration, or FDA, is part of the United States government. It is FDA's job to make sure medical treatments are safe and effective for people to use.

What is a Clinical Trial?

"Clinical trial" is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the drug or device is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible.

Why Should Minorities and Women Participate In Clinical Trials?

In the past, most drug testing has been done on white men. This means that some groups, such as African Americans, Hispanic Americans, American Indians, Asian Americans, and women, have not always been included in the tests done on drugs. But sometimes drugs work differently on people in these groups than on white men. So FDA wants people from many different groups included in these studies.

Points to Remember

Informed Consent Protects Volunteers

To help you decide if you want to be a volunteer in a study, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that volunteers be told:

Informed consent information should be written so you can understand it. If you don't, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.

Before you can participate in the trial, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.

Other Ways Volunteers Are Protected

Why Volunteer?

By taking part in a clinical trial, you can try a new treatment that may or may not be better than those already available. You can also contribute to better understanding of how the treatment works in people of different ethnic backgrounds and genders.

What Are the Risks?

Many studies require that neither the patient nor the doctor know whether the patient is receiving the experimental treatment, the standard treatment or a placebo (an inactive substance that looks like the drug being tested). In other words, some volunteers may be getting no treatment at all.

Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors don't always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and should be fully explained to you in the informed consent material.

Questions to Ask

Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:

This information has been obtained from FDA and is updated by Life Alert ® frequently.